Clorazepate Dipotassium Tablets Recalled for Tablet Discoloration Defects Nationwide
Aurobindo Pharma USA Inc. is recalling 6909 bottles of Clorazepate Dipotassium 7.5 mg tablets due to visible discoloration with yellow and dotted spots. No illnesses or injuries have been reported.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves a visible quality defect with no reported illnesses or injuries. The discoloration is a manufacturing or packaging defect that warrants a precautionary recall, meeting the moderate severity threshold.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Clorazepate Dipotassium Tablets, USP, 7.5 mg, manufactured in India and distributed nationwide. The recall involves 6909 bottles in 100-tablet and 500-tablet package sizes with lot numbers CZB124001B, CZB124002B, CZB124003B (100-tablet bottles, expiration 12/31/2025) and CZB124001A, CZB124003A (500-tablet bottles, expiration 12/31/2025). The product is distributed by Aurobindo Pharma USA, Inc., East Windsor, NJ.
The tablets have been identified with visible discoloration, manifesting as dotted and yellow spots. The recall notice does not provide information about the cause of the discoloration or its impact on drug safety or effectiveness.
Consumers with affected bottles should not use them and should return the product to their pharmacy or to Aurobindo Pharma USA Inc. At the time of this recall, no illnesses or injuries have been reported.
The recalled product
- Product
- CLORAZEPATE DIPOTASSIUM (CLORAZEPATE DIPOTASSIUM)
- Brand
- CLORAZEPATE DIPOTASSIUM
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug
- Hazard
- Affected units
- 6,909
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot #s: a) CZB124001B
- CZB124002B
- CZB124003B
- Exp. 12/31/2025
- b) CZB124001A
- CZB124003A
- Exp. 12/31/2025.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Aurobindo Pharma USA Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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